RecruitingPhase 1NCT04329494

PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer

Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)


Sponsor

City of Hope Medical Center

Enrollment

49 participants

Start Date

Aug 21, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and/or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a technique called PIPAC (Pressurised IntraPeritoneal Aerosol Chemotherapy), which delivers chemotherapy directly into the abdominal cavity as a fine mist during a minimally invasive procedure. It is being studied for people with cancer that has spread throughout the lining of the abdomen (peritoneal carcinomatosis) from ovarian, uterine, appendix, colorectal, or stomach cancer. **You may be eligible if...** - You have been diagnosed with ovarian, uterine, gastric, appendiceal, or colorectal cancer that has spread to the abdominal lining - Your cancer has progressed despite at least one standard chemotherapy regimen - You are in reasonably good physical condition (ECOG 0–2) - Your blood counts and organ function are within acceptable ranges - You are able to safely undergo a minimally invasive (laparoscopic) procedure **You may NOT be eligible if...** - You have a condition that prevents laparoscopic surgery - Your cancer has not been previously treated with chemotherapy (for most arms) - You have very poor kidney, liver, or blood function - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo biopsy

DRUGCisplatin

Given via PIPAC

DRUGDoxorubicin

Given via PIPAC

DRUGFluorouracil

Given IV

DEVICEIntraperitoneal Chemotherapy

Undergo PIPAC

DRUGIrinotecan

Given IV

DRUGLeucovorin

Given IV

DRUGMitomycin

Given via PIPAC

DRUGOxaliplatin

Given via PIPAC

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies


Locations(3)

City of Hope Medical Center

Duarte, California, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Northwell Health Cancer Institute at Huntington

Greenlawn, New York, United States

View Full Details on ClinicalTrials.gov

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NCT04329494


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